Burlando Martina, Fabbrocini Gabriella, Marasca Claudio, Dapavo Paolo, Chiricozzi Andrea, Malvaso Dalma, Dini Valentina, Campanati Anna, Offidani Annamaria, Dattola Annunziata, Caro Raffaele Dante Caposiena, Bianchi Luca, Venturini Marina, Gisondi Paolo, Guarneri Claudio, Malara Giovanna, Trifirò Caterina, Malagoli Piergiorigio, Fargnoli Maria Concetta, Piaserico Stefano, Carmisciano Luca, Castelli Riccardo, Parodi Aurora
Division of Dermatology, Department of Health and Science (DissaL), Policlinico San Martino Hospital, IRCCS, 16132 Genova, Italy.
Department of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II, 80131 Naples, Italy.
Biomedicines. 2022 Oct 9;10(10):2522. doi: 10.3390/biomedicines10102522.
This study aimed to compare adalimumab originator vs. biosimilar in HS patients, and to evaluate the effect of a switch to a biosimilar, or a switch back to the originator, in terms of treatment ineffectiveness. Patients with a diagnosis of HS were enrolled from 14 Italian sites. Treatment ineffectiveness was measured using Hurley score. The major analyses were 1) comparison between the two treatment groups (non-switcher analysis), and 2) the cross-over trend of Hurley score between treatment switchers (switcher analysis). Cox and Poisson regression models were used to compare the treatment ineffectiveness between groups. A total of 326 patients were divided into four groups: 171 (52.5%) taking originator; 61 (18.7%) patients taking biosimilar; 66 (20.2%) switchers; 28 (8.6%) switchers from originator to biosimilar and switched. A greater loss of efficacy was observed in the group allocated to the biosimilar than the originator group. The switcher analysis showed an effectiveness loss in the biosimilar compared to the originator. These results seem to indicate that a switch from one drug to the other may lead to a greater risk of inefficacy. A return to the previous treatment also does not ensure efficaciousness.
本研究旨在比较阿达木单抗原研药与生物类似药在化脓性汗腺炎(HS)患者中的疗效,并评估改用生物类似药或换回原研药对治疗无效的影响。从意大利14个地点招募了诊断为HS的患者。使用赫尔利评分来衡量治疗无效情况。主要分析包括:1)两个治疗组之间的比较(非换药者分析),以及2)治疗换药者中赫尔利评分的交叉趋势(换药者分析)。使用Cox和泊松回归模型比较组间治疗无效情况。总共326例患者分为四组:171例(52.5%)服用原研药;61例(18.7%)服用生物类似药;66例(20.2%)换药者;28例(8.6%)从原研药换为生物类似药又换回原研药的患者。与原研药组相比,分配到生物类似药组的患者观察到更大的疗效丧失。换药者分析显示,与原研药相比,生物类似药存在疗效丧失情况。这些结果似乎表明,从一种药物换为另一种药物可能导致更高的治疗无效风险。换回之前的治疗也不能确保疗效。